Proton pump inhibitors: very low risk of subacute cutaneous lupus erythematosus
- Medicines and Healthcare products Regulatory Agency
- 8 September 2015
- Therapeutic area:
- Dermatology and GI, hepatology and pancreatic disorders
Proton pump inhibitors (PPIs) are associated with very infrequent cases of subacute cutaneous lupus erythematosus (SCLE), a non-scarring dermatosis that can develop in sun-exposed areas.
If a patient treated with a proton pump inhibitor (PPI) develops lesions—especially in sun-exposed areas of the skin—and it is accompanied by arthralgia:
- advise them to avoid exposing the skin to sunlight
- consider subacute cutaneous lupus erythematosus (SCLE) as a possible diagnosis
- consider stopping use of the PPI unless it is imperative for a serious acid-related condition; a patient who develops SCLE with a particular PPI may be at risk of the same reaction with another
- in most cases, symptoms resolve on PPI withdrawal; topical or systemic steroids might be necessary for treatment of SCLE only if there are no signs of remission after a few weeks or months
- report any suspected side effect with PPIs, or to any medicine, on a Yellow Card
Proton pump inhibitors
PPIs reduce the secretion of stomach acid and are widely used medicines for management of acid-related conditions, including: reflux oesophagitis; gastric and duodenal ulcers; and Zollinger-Ellison syndrome. The following PPIs are available in the UK:
Subacute cutaneous lupus erythematosus
SCLE is characterised by polycyclic erythematous scaly plaques or confluent psoriasiform papulosquamous lesions, which may be accompanied by arthralgia. Skin tests (such as direct immunofluorescence) and serological tests (including presence of antibodies against Ro or Sjögren’s-syndrome-related antigen A [SSA]) can be used to diagnose SCLE.
Drug-induced SCLE can occur weeks, months or even years after exposure to the drug.
Evidence for the association
Considering the extensive use of PPIs, very few cases of SCLE have been reported. Nevertheless, evidence from clinical literature and from cases reported to medicines regulators including via the Yellow Card Scheme supports a causal association between PPIs and SCLE. Product information is being updated to include this advice for healthcare professionals and patients or carers.
A Swedish case-control study that linked a patient register with a prescribed-drug register estimated that the risk of developing SCLE was almost 3 times higher in patients on PPIs compared with that of the general population (odds ratio 2.9 [95% CI: 2.0–4.0]).1
A review of medical records of patients at a dermatology unit in a university hospital in Denmark identified 19 cases of SCLE associated with PPIs over 19 years. Of these, 3 cases were classified as definitely caused by a PPI and 14 were classified as probable.2
Cumulatively, of the cases reviewed from literature and from case reports submitted by PPI licence holders to medicines regulators, there have been 36 cases of positive dechallenge (ie, SCLE resolved on stopping PPI) and 4 cases of positive rechallenge (ie, SCLE reoccurred with a different PPI to the one that first triggered the condition).
Article citation: Drug Safety Update vol 9 issue 2 September 2015: 1.
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Published: 8 September 2015